workshops organized to date
Regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, thereby facilitating sound and transparent regulatory decision making. It differs from 'classical' academic sciences in the sense that questions posed often originate from government bodies, industry, medical professionals, patient organizations, and NGOs. Those questions focus on increasing the efficiency of the regulatory system, in order to improve its effectiveness on the basis of scientific research results.
RSNN is a network of experts from industry, academia, government bodies, and the broader regulatory science field. Our mission is to advance an efficient and effective regulatory system that supports medicines development, marketing authorization, access, and appropriate use of medicines. RSNN shares and disseminates knowledge among all stakeholders and sets the agenda for further research.
RSNN was founded on October 5, 2015, during the FIGON Dutch Medicines Days. It was initiated by the Medicines Evaluation Board (MEB), the TI Pharma Escher project, and the Dutch Society of Pharmaceutical Medicine, in order to consolidate and strengthen national research networks in the field of regulatory science.
Coordinating inclusive dialogue towards impactful output
In 2018, Lygature coordinated strategic discussions that led to RSNN becoming a partnership. As one of the four partners, Lygature provides the necessary managerial and scientific expertise, ensuring inclusive discussions and meaningful outputs. Activities include:
- Coordination, program management and communications. Lygature handles day-to-day operations of the RSNN including administrative, financial, and communications activities. Lygature provides strategic advice to the RSNN board and helps to define future directions.
- Stakeholder management. Lygature is responsible for the inclusion and involvement of relevant stakeholders in the RSNN. This includes identifying opportunities for future support of the network’s activities (e.g. through financial and in-kind contributions).
- Scientific management. Lygature assists the RSNN in identifying topics for scientific meetings, co-organizing the meetings, and ensuring that RSNN events lead to impactful outputs.
RSNN makes an important contribution to Lygature’s mission of accelerating the launch of new medicines for patients. The project has required extensive management capabilities, along with expertise in both science and the regulatory landscape.
Lygature together with
Future of the drug label: Perspectives from a multistakeholder dialogue
Recently, the British Journal of Clinical Pharmacology published a paper by members of the RSNN on the future of the drug label. The paper is based on the 3rd RSNN Workshop ‘What’s in, What’s out, What’s relevant? – Towards a sensible label’ which was held in June 2018. During this workshop, a multistakeholder dialogue was set up between academia, government, the pharmaceutical industry and patient/societal organizations. Read more about the outcomes here.
RSNN responds to EMA’s draft strategy ‘Regulatory Science to 2025’
In December 2018, the European Medicines Agency (EMA) published its draft strategy ‘Regulatory Science to 2025’, describing the plan for advancing EMA’s engagement with regulatory science over the next five to ten years. The draft was published for a public consultation, in which EMA stakeholders can share their views on the strategic document. The RSNN has formulated a response on the human medicines part of this strategic document.
Regulation is too important to leave it to the regulators
Last month, professor Bert Leufkens published an editorial in the British Journal of Clinical Pharmacology.
In the article, Leufkens, who is part of the leadership team at Lygature, makes the case for how regulatory science (including fields such as behavioral sciences, decisions theory and innovation sciences) has a valuable role in better understanding which factors contribute to a certain outcome and how the regulatory system can align with broader societal goals and interest. As such, regulatory science can have an informed impact on the development of a thriving regulatory, health care and business ecosystem.
Read the full editorial titled 'Regulatory science: Regulation is too important to leave it to the regulators' here (free access).